JP4401774B2 - Inhalation actuator - Google Patents

Abstract

A device for dispensing medication in an aerosol form from an MDI which is activated by a scource of compressed air which is pressurized ba a compression piston (38) in association with a cooking lever (56) which also acts as a mouthpiece cover (18) wherein the device automatically discharges the medication upon inhalation on the mouthpiece. The device also has a detachable component (14) for alternative use as a press and breathe type inhaler.

Description

Background of the Invention

1. FIELD OF THE INVENTION This invention relates to a device for delivering medication to the lungs by inhalation actuation and is used to deliver a fluid formulation from a can container containing the medication. The delivery device delivers a predetermined dose of medication or other therapeutic agent when the patient inhales the device or pushes the can container portion of the device.

2. Brief Description of Related Art There are a variety of inhalation devices that release nebulized drugs, either a continuous release with a spray or a pre-determined amount of drug, typically a predetermined dose. It is a form. Sprays are sprayed directly into the patient's mouth, nose, or respiratory tract. In general, these devices are activated by pressure generated by a user's finger, button operation, or other related manual method. Some devices operate by inhalation by the user, and some are good, but all require changes or improvements.

  Various drug companies produce pre-determined dose spray containers containing drugs to be inhaled in the mouth, nose or respiratory tract. Therapeutic drugs usually given by the inhalation route include bronchodilators (B2 agonists (agents) and anticholinergics), corticosteroids, and antiallergic drugs. Inhalation can also be performed for anti-infective drugs, vaccines, systemic effects and diagnostic drugs as well as anti-leukotrienes and and-proteases. A given dose spray drug is in many ways the same as an undefined dose spray drug, with the difference that no continuous spray is released when the valve is depressed. Instead, a predetermined volume is released as a spray and a fixed amount of drug is released.

  Several types can be used as the predetermined dose inhaler. The most common one has a room for pressure-resistant containers (can containers). The container is usually filled with a product above atmospheric pressure, such as a drug dissolved in a liquefied propellant, or fine particles suspended in the liquefied propellant. Install a metering valve on the container. The metering valve is movable from the outer (filling) position to the inner (discharge) position. The metering valve is kept in the filling position by the force of the spring until it is pushed into the discharge position. When the metering valve is activated, the metered portion of the container contents is released, thereby bringing the dissolved or tiny drug out of the container to the patient with the pressure of the liquefied propellant. The valve actuator also directs the spray medication as a spray into the patient's oropharynx. Surfactants usually dissolve in spray formulations and perform two functions: the function of lubricating the valve and the function of reducing agglomeration of microparticles. For examples of such predetermined dose inhalers, US Pat. No. 5,514,647 entitled “Predetermined Dose Inhaler” and US Pat. No. 5, entitled “Counter for Fluid Dispensing” No. 622,163, as well as US patent application Ser. No. 09 / 241,010 filed Feb. 1, 1999 (assigned to the same person) as the title of the invention “stirring device for a predetermined dose inhaler”. The content they show is hereby incorporated by reference.

  A typical example of a pharmaceutical formulation for use in a predetermined dose inhaler is that shown in US Pat. No. 5,190,029. Prescription dose inhalers for administering such pharmaceutical formulations are also found in the examples in the description of, for example, U.S. Pat. Nos. 3,361,306, 3,565,070 and 4,955,371. ,well known. They are incorporated herein by reference.

  A wide variety of fluid delivery devices are known and commercially available for dispensing a metered portion of fluid contained in a container from the container. For example, U.S. Pat. No. 3,749,290 shows a trigger-actuated feed pump attached to a fluid container. In response to actuation, a metered portion of the fluid contained therein is supplied from the container.

  Inhalers of the “pumping” type are known so far. The device performs pumping manually (eg, as shown in US Pat. No. 5,284,132) or utilizes a series of operations such as a pump. The drug can be repeatedly released from the pressurized can container, and spraying or inhalation can be repeated as necessary.

  In order to properly use these manually operated devices, it is necessary to generate a spray at the beginning of the inhalation cycle. This allows the drug to be carried into the lungs rather than being deposited in the mouth and throat. If this operation does not match the inhalation phase correctly, the prescribed dose will vary from one operation to the next, and the therapeutic power and safety of the drug (product) may be compromised.

  There are a number of factors that do not match the spray action with the suction. Among these factors is the user's inherent constraints (if any), such as incomplete physical strength of the elderly or children, or the lack of any group ability, and an accurate understanding of device usage May not be possible. Recognizing that it is necessary to deliver drugs accurately and accurately to asthma patients, COPD patients, and other patients with respiratory illness, a reliable breathing device can help these sufferers. It will be possible to improve the quality of life. Examples of breath actuating devices include US Patent No. 5,069,204, entitled "Inhaler", and US Patent Application No. 09 / 567,352, entitled "Inhaler Actuating Device". The content they show is hereby incorporated by reference.

  Accordingly, the object of the present invention is economical to manufacture, very easy to use, and correctly delivers each dose metered in response to breathing action (more specifically, inhalation). To provide an inhaler.

  It is another object of the present invention to provide an inhaler that is breathable by removing a dispenser / mouthpiece assembly that can be pushed to inhale a dispensed drug.

  In order to achieve the above-described object, the present invention uses a pneumatically operated predetermined dose supply device for supplying a spray medicine. The device has a housing that defines a body portion in which a drug-containing can container is held. The device also has a mouthpiece that is placed in the patient's mouth. A mechanical lever with a mouthpiece moves the compressor pump, and after the device is filled with compressed gas by the pumping action and kept in the second chamber, a vacuum is drawn when the user inhales the device. Thereby causing the switching valve to operate. Correspondingly, the compressed gas enters the room holding the drug-containing can container. As a result, the valve stem of the can container is pushed, and the medicine is released in a spray form. This release of drug occurs simultaneously with inhalation and ensures that a predetermined dose of drug is delivered to the intended location. In other words, the drug is not delivered off the throat or upper mouth. Since the device of the present invention begins to deliver medication by inhalation, even small children (6-12 years) and older patients can easily operate.

  In an additional embodiment of the invention, the dispenser / mouse piece assembly mounted within the housing of the device can be removed. By removing it, the assembly can be used as a type of feeder for pushing and inhaling. This has the advantage of becoming a backup (alternative) when the respiratory actuation characteristics of the device are unsuccessful. In general, the dispenser / mouthpiece assembly can be replaced with a depleted dispenser.

Detailed Description of the Preferred Embodiment

  Looking more closely at the drawings, an inhalation actuator 10 is shown in FIG. 1 and includes a housing 12 containing a mouthpiece / can container assembly 14. In the inhalation actuation device 10 of FIG. 1, the mouthpiece / can container assembly 14 is removable, but the mouthpiece 16 and associated actuation components can be configured as part of the device 10.

  In operation of the mouthpiece / can container assembly, the can container stem 22 strikes the surface (receiving portion) 26 in response to the displacement of the can container while the pressure is activated. The drug is released as an aerosol from the can container stem. A nozzle 24 directs the spray through the mouthpiece 16.

  An outer wall 28, an upper surface 30 and a partition wall 32 define the first chamber 20 in the device 10. Also, the partition wall 32, the upper surface 30 and the outer wall 36 form a second chamber 34 on the other side of the partition wall 32. A movable piston 38 provides the lower surface of the second chamber 34. The volume of the second chamber varies depending on the position of the piston 38 in the chamber (FIG. 1 is in a resting state). In operation, the piston compresses the initial volume of gas to a small volume. Thereby, the pressure of the gas increases. This compressed gas energy is used to release the drug in the can (described later).

  The device 10 has a third room 40. The outer wall 28, the upper surface 30, the switching valve cover 42 and the air passage cover 44 define the third chamber 40. The third chamber 40 is a refill reservoir for supplying air to the second chamber 34 when the movable piston 38 is reset (returned to the initial state) (also described later).

  The upper portion of the piston 38 is attached to the lower piston support 46 that constitutes the compression piston assembly 48. The compression piston assembly 48 has a first end 52 of the articulation link 50. The second end 54 of the connecting link 50 is attached to the first end 55 of the start preparation lever 56. The starter preparation lever 56 is rotatably supported around the attachment rod 58 in the axial direction. The attachment rod 58 securely attaches the start preparation lever 56 to the housing. The second end 60 of the starter preparation lever 56 is attached to the mouthpiece 18 by means of a connecting pivot 62.

  In operation, the starter preparation lever 56 rotates and moves between a rest position and a discharge position. When the inhalation device 10 is in the rest position, the start-up preparation lever 56 is close to the lower side 63 of the device, and the mouse pi scuba 18 protects the mouse piece 16.

  The piston 38 is sized to fit snugly against the inner wall of the second chamber 34 and compresses the fluid (gas or air) inside the second chamber 34 when it is moved to the start-up ready position. The piston 38 has a U-cup seal 64 mounted within its opening 66 to prevent leakage of compressed fluid from the side. As the piston seal, a rolling diaphragm seal or a bellows type can be used.

  The upper surface 30 in the second chamber 34 also has a passage 67 made of an elastic polymer material, into which an umbrella-like check valve 68 enters. As the starter preparation lever 56 is moved toward the body of the apparatus 10, the articulating link 50 pulls the compression piston 38 downward. By this movement, ambient air is drawn into the second chamber 34 from the mouthpiece 16 or the holes (openings) 103 and 104 of the third chamber 40 through the passage 67 and the umbrella-shaped check valve 68. .

  The upper surface 30 in the second chamber 34 also has a hole 69 with a high pressure orifice 70 mounted therein. As shown in FIG. 2, when the start-up lever 56 is moved away from the mouthpiece 16 and toward the body of the device, the articulating link 50 pushes the compression piston 38 upward. The start preparation lever 56 and the connecting link 50 constitute a toggle so that the compression piston 38 is kept closest to the top prior to the trigger (start of discharge). A toggle stop 71 is fixed to the partition wall 32 to prevent an over action (over movement) of the start preparation lever 56.

  The upward movement of the compression piston 38 pushes the compressed fluid from the high pressure orifice 70 toward the diaphragm 72 made of an elastic polymer material. Diaphragm 72 is hermetically sealed by retaining its periphery between the switching valve cover 42 and the upper surface 30 of the housing. As shown, the diaphragm 72 is adjacent to the cavity 73 and also provides a portion of the fluid passage 74. When the passage 74 is open, the passage 74 and the second chamber 34 communicate with each other. There is also a switching port 76 which is an orifice communicating with the chamber 20a which is a sub chamber of the room 20. The sub chamber 20a is located between the surface 30 and the working piston 78 and is shaped by its movement. When the passage 74 is open, the passage 74 and the subchamber 20a are also in communication with each other and compressed fluid flows from the second chamber 34 to the subchamber 20a, increasing the size of the subchamber 20a (FIG. 3 becomes more apparent). Is shown).

  The working piston 78 includes a U-cup seal 80. Prior to the trigger (start of discharge), the piston 78 is located at the upper end of the sub chamber 20a. The lower part of the piston 78 is in contact with the can container 81.

  There is little, if any, open space between the lower portion of the upper surface 30 and the working piston 78. Actuating piston 78 fits snugly into housing wall 12 and partition wall 32. The fit is to ensure a seal and prevent leakage when the compressed fluid is released from the second chamber 34. For the working piston 78 (and also for the compression piston), various configurations can be employed. In its form, it includes a rolling diaphragm, or a vero-type, and other means suitable for the purpose.

  There is a sheet 82 above the diaphragm 72. The sheet 82 passes through the switching valve cover 42 and pushes the diaphragm 72. Thereby, a reverse force is applied to the compressed air in the second chamber 34, and the seal of the diaphragm 72 is secured.

  At its uppermost portion 82A, the sheet 82 intersects the end of the lever 83. The lever 83 helps to move (trigger) the diaphragm 72. The opposite end of the lever 83 intersects the composite diaphragm 86. The opposite side of the diaphragm 86 is opened to the atmosphere through a hole 88. The lever 83 is rotatable about a pivot point 84.

  Diaphragm 72 remains sealed with the force of spring 98 before triggering and after compressing fluid into chamber 34.

  The operation of the preferred embodiment described above is performed as follows. After placing the mouse piece / can container assembly 14 into the first chamber 20, the user removes the mouse piece cover 18 that protects the mouse piece 16 with a finger from the protected position, and the mouse piece cover 18 is removed. Is aligned with the start preparation lever 56. Then, the user moves the starter preparation lever 56 toward the apparatus and moves it out of the housing, as shown in FIG. When the start-up lever 56 moves in this manner, the articulation link 50 pushes the compression piston 38 upward. By moving the compression piston 38 upward, the volume of the chamber 34 is reduced and the fluid inside is compressed.

  As shown in FIG. 3, when the user inhales from the mouthpiece 16, the inside of the apparatus is evacuated (reduced pressure) (particularly in the first and third chambers 20, 40 and through the vent orifice 100). In the upper space 73 above the fluid passage 74). The internal vacuum immediately creates a differential pressure across the diaphragm 72 and the composite diaphragm 86. For diaphragm 72, a certain threshold is immediately exceeded and the force of spring 98 can no longer keep the diaphragm in the sealed position. As part of this, the resulting vacuum causes the diaphragm 86 to be sucked to some extent, rotating the lever 83 about the pivot point 84 and applying an upward force to the sheet 82. This, in combination with the differential pressure on the diaphragm 72, opens the diaphragm 72. Once opened, the compressed fluid exits the second chamber 34, enters the first chamber 20 from the switching port 76 through the fluid passage 74, applies pressure to the working piston 78, and expands the subchamber 20a. The force acting on the actuating piston 78 overcomes a return spring (not shown) in the can container stem 22 and moves the can container 81 and / or the stem to spray and supply the drug. The drug is supplied through the nozzle 24 and the mouthpiece 16.

  It should be noted that when the user inhales, the atmosphere is drawn through the holes (openings) 103, 104, allowing the user to inhale while the differential pressure or vacuum sign is triggered to trigger the device. It is. Accordingly, these holes (openings) 103, 104 are sized to adjust the pressure drop inside the device that occurs as the user inhales. This controls when the device is triggered. Furthermore, the openings 103 and 104 supply fresh air to the room 34 through the room 20, the passage 28, the room 40 and the passage 67.

Outlet 105 at the top of the hydraulic piston 78 slowly flows out of the compressed air between the upper surface 30 and the piston 78. Thereby, the can container return spring returns the piston to its original position without user intervention. This prevents leakage of the can container that occurs when the valve stem is kept pressed for a long time. When the pressure inside the entire apparatus becomes equal, the diaphragm 72 is returned to the seal position by the force of the spring 98, and the lever 83 changes its position.

  The dwell time and outflow function of the outlet 105 can be met by placing a porous chamber (7 μm) membrane in the hole of the working piston 78 where the outlet is located. By using a porous chamber film, it is possible to prevent the outlet from being blocked or obstructed by waste as much as possible.

  It will be apparent to those skilled in the art that the inhalation and release of the drug from the canister is very rapid. The rate is on the order of about 200 milliseconds (ms), and inhalation of the drug can be started at the start of inhalation. It can then be delivered to a surface area (usually the lungs) aimed at a greater degree of drug than normal.

  Now, looking at FIGS. 4 to 6 in more detail, the appearance of the inhaler 10 and the operation (movement) apparent to the user are shown. FIG. 4 shows the inhalation device 10 in a resting state. The start preparation lever 56 is stationary on the lower side 63 of the housing 12, and the mouse pi scuba 18 protects the mouse piece 16. There is a notch in the lower side 67 of the housing 12 to fit the starter preparation lever 56. FIG. 5 shows the mouse piece 16 with the finger removed in the downward direction 110 and the mouse piece 16 with the cover removed and the lever 56 ready.

  FIG. 6 shows the lever 56 after it has finished moving in the direction 112 and is ready to start. The inhalation device 10 can now be used.

  In other embodiments, the mouthpiece / can container 14 can be removed from the inhalation device 10. As shown in FIG. 7, the mouthpiece / can container assembly 14 can be separated by a plug-in type locking mechanism 112. The locking mechanism 112 releases the mouthpiece / can container assembly 14 in response to rotation. When the start-up preparation lever 56 is in the start-up position, the mouthpiece / can container assembly 14 can be removed. When the mouthpiece / can container assembly 14 is removed, the can container 81 can be easily replaced, and the mouthpiece / can container assembly 14 can be used as a separate-type feeder that pushes and inhales the mouthpiece / can container assembly 14. . Upon insertion, the locking mechanism 112 rotates and snaps into the pore 118, securing the mouthpiece / can container assembly. When at rest, the start-up lever 56 and the mouthpiece scuba 18 additionally secure the mouthpiece / can container assembly within the inhaler 10. Of course, other means suitable for the purpose can be applied as means for securing the mouthpiece / can container assembly 14 to the inhalation device 10 as will be apparent to those skilled in the art.

  The objects and advantages of the present invention will become apparent from the foregoing description. Although the preferred embodiment has been described in detail, the invention is not limited to that description. The technical scope of the present invention is determined by the claims.

It is sectional drawing of the apparatus of this invention, and has shown the dormant state. It is sectional drawing of the apparatus of this invention, and has shown the preparation state. FIG. 2 is a cross-sectional view of the device of the present invention, showing a discharge (starting) state. It is an external view of the apparatus of this invention of a dormant state. It is an external view of the apparatus of this invention of the state which removed the mouse | mouth pi scuba. It is an external view of the apparatus of this invention of a preparation state. FIG. 6 is an external view of another embodiment of the present invention, showing the mouthpiece / can container assembly separated from the apparatus.

Explanation of symbols

10 Inhalation Actuator 12 Housing 14 Mouse Piece / Can Container Assembly 16 Mouse Piece 18 Mouse Piece Scuba
20 first chamber 34 second chamber 38 piston 40 third chamber 50 articulated link (arm)
56 Start preparation lever
70 High pressure orifice 72 Diaphragm 78 Actuating piston 81 Can container 86 Diaphragm

Claims (15)

An inhalation operation device, which is a device for supplying a medicine and operates by inhalation by a patient, and includes the following configurations (a) to (f).
(A) For holding a drug-containing can container (81), which is in contact with a mouthpiece (16) into which a patient inhales a predetermined dose of drug to be sprayed in a mist, the can container ( There is an actuating means (78) acting on 81), which actuating means (78) is in communication with a first fluid passage (76) that can be opened and closed;
(B) a compression piston (38) for compressing the second chamber (34) , and further comprising outlet means (70) communicating with the openable first fluid passage (76); Room (34)
(C) A mouse piece scrubber (18) for protecting the mouse piece (16), which can be rotated off the mouse piece (16).
(D) A first end is rotatably connected to the mouthpiece (18), a second end is attached to the compression piston (38), and the compression piston (38) is attached to the second piston (38). Moveable arm means (50, 56) for moving the interior of the chamber (34) in at least one direction and compressing the fluid in the second chamber (34)
(E) Seal means (72) for sealing the first fluid passage (76) in a closed state.
(F) holding the sealing means (72) in a closed state, and opening the sealing means (72) when the differential pressure generated by the user's inhalation exceeds a threshold value, and the compressed fluid Means for operating the actuating means (78) and displacing the can container (81) to supply a predetermined dose of medicine to the user   In the first chamber (20), there is a receiving part (26) that hits the valve stem (22) of the can container (81) according to the displacement of the can container (81) or its valve stem (22). The apparatus of claim 1.   The first chamber (20) has openings (103, 104) sized to adjust the pressure drop inside the device to adjust the differential pressure required to open the sealing means (72). The device of claim 1 wherein:   The apparatus of claim 1, wherein the second chamber (34) has an opening for drawing fluid into the second chamber (34).   The apparatus of claim 4, wherein the opening has means (68) for sealing the second chamber (34) when compressing fluid into the second chamber (34).   The apparatus of claim 1, wherein the first fluid passage (76) is defined by a passage between the actuating means (78) and the second chamber (34).   The apparatus of claim 1, wherein said sealing means (72) comprises a first diaphragm disposed within said first fluid passage (76).   The apparatus of claim 6, wherein the seal means (72) comprises a first diaphragm disposed within the first fluid passage (76).   The apparatus of claim 1, wherein the means for holding the sealing means (72) closed comprises biasing means including a compression spring (98) for applying a biasing force to the first diaphragm closed. .   The apparatus of claim 9, further comprising a rotatable lever assembly (83) coupled to the first diaphragm.   The apparatus of claim 10, wherein the rotatable lever assembly (83) includes a second diaphragm (86) mating thereto.   When the differential pressure on the second diaphragm (86) exceeds a threshold, the second diaphragm (86) exerts an upward force on the first diaphragm against the rotatable lever assembly (83). 12. The device of claim 11, wherein the device is generated and helps the first diaphragm to open.   The can container (81) containing the medicament is operably connected to a removable supply device, the removable supply device comprising the actuating means (78) and the mouthpiece (16). Item 1. The apparatus of item 1.   The actuating means (78) comprises an outflow opening (105) for controlling the dwell time for delivering a predetermined dose of medication and returning the canister (81) to its previous operating position. 1 device.   The apparatus of claim 14, wherein the outlet opening (105) is a porous membrane.

Images